• Toxicological Research
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• 제22권2호
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• pp.109-116
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• 2006

Safety pharmacology studies are conducted to investigated the potential undesirable pharmacodynamic effects of a substance on physiological functions in relation to exposure in the therapeutic range and above. In the International Conference on Harmonisation (ICH), the guideline 'S7A: Safety Pharmacology Studies for Human Pharmaceuticals' has been developed and reached Step 5 of the ICH process in 2001. Now the Korea Food and Drug Administration (KFDA) are going to transfer 'The Guideline for General Pharmacology' into 'The Guideline for Safety Pharmacology'. Safety pharmacology studies should be performed in compliance with Good Laboratory Practice (GLP). Thus, the present paper reviews the Japanese GLP guidelines for pharmaceuticals to help the conduct and inspection of safety pharmacology studies in compliance with GLP. We also reviewed the ICH guidelines 'S7B revised : The Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals' and 'E14 : The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-antiarrhythmic Drugs' to apply our drug approval systems.

• Journal of Nutrition and Health
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• 제57권1호
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• pp.1-15
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• 2024

한국인을 위한 식생활지침은 건강한 식생활을 위한 가이드로 활용되는데, 식생활지침에 대한 세부 항목이 제시되지 않아서 지침에 대한 실천도를 자세히 평가하기는 어렵다. 따라서 본 연구는 식생활지침 실천도를 평가할 수 있는 세부 항목들을 선별하여 지침 실천도를 평가하는 평가도구를 만들고자 수행되었다. 노인의 식생활지침 실천 평가도구 개발을 위하여 문헌검토와 전문가 자문을 거쳐 총 35개의 평가 후보 항목을 추출하고, 전국단위 5개 지역의 남녀 노인 800명 (남 400명, 여 400명)을 대상으로 설문조사를 수행하였다. 식생활지침의 세 가지 영역별로 후보 항목에 대한 탐색적 요인분석으로 평가도구에 사용될 항목을 선별하고, 확인적 요인분석을 수행하여 구성타당도를 검증하였다. 구조방정식 모형의 경로계수를 활용하여 항목별 가중치를 부여하여 식생활지침 실천 점수를 계산하고, 전국조사 결과를 바탕으로 평가도구의 등급 체계를 마련하였다. 본 연구에서 개발된 노인 식생활지침 실천 평가도구는 총 28개 항목으로 식품섭취 영역 13항목, 식생활습관 영역 7항목, 환경을 생각하는 식생활 문화 영역 8항목으로 구성되었다. 식품섭취 영역에는 신선 생채소, 황색채소, 생과일, 콩·견과류, 생선·해산물, 고기·달걀 섭취, 우유·유제품, 잡곡 섭취, 물, 다양한 식품군 섭취, 육류 가시지방 제거, 단 음료, 염장 식품 섭취 항목이 포함되었고, 식생활습관 영역에는 건강체중 유지, 활동량 증가 노력, 운동, 과식정도, 과음빈도, 아침식사 빈도, 식사의 규칙성 항목이 포함되었다. 환경을 생각하는 식생활문화 영역에는 조리 및 음식 먹기 전 손 씻기, 유통기한 (소비기한) 확인, 개인 접시에 덜어 먹기 실천, 냉장고에 보관한 음식 덜어 먹기, 제철음식 섭취, 지역 농산물 이용, 식품 원산지 확인, 음식물 쓰레기 줄이기가 포함되었다. 전국설문조사 노인 (n = 800)의 식생활지침 실천 평균 점수는 56.9점이었고, 식품섭취 영역 49.8점, 식생활습관 영역 63.2점 그리고 식생활문화 영역은 58.6점이었다. 식생활지침 실천 점수는 기 개발된 노인 영양지수 및 식품정보이해력 점수와도 유의한 상관성을 보여서 식생활지침 실천 평가 도구가 식품섭취와 식행동 뿐만 아니라 지속가능한 식생활 실천 부분도 잘 반영한다는 것을 확인할 수 있었다. 앞으로 노인 맞춤형 식생활지침 실천 평가 도구가 노인들의 식품섭취, 식생활습관 및 식생활문화 영역를 종합적으로 평가하는 쉽고 간편한 검색 평가 도구로 활발하게 활용될 것으로 기대된다.

• 동아시아식생활학회지
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• 제16권3호
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• pp.251-260
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• 2006

To study the correlation between body composition values and practice of the Standard Guideline for Korean Dietary Life, a nationwide cross-sectional survey was conducted with 378 female college students living in four Korean cities in December 2005. Among the student subjects, 98 were analyzed for body fat mass, percent body fat, waist-hip ratio(WHR), body mass index(BMI) and obesity degree using Inbody 3.0(Biospace Co, Seoul, Korea). Percent body fat was at a high level of 54.1 %, WHR was at a high level of 58.2% and BMI was at a high level of 41.8%. However, both weight and body fat were below normal at 79.5% and 77.6%, respectively. Percent body fat, WHR, and BMI were slightly negatively correlated with vegetable consumption, but slightly positively correlated with beer intake. WHR > 0.8 was significantly negatively correlated with exercise. Standard Guideline for Korean Dietary Life was practiced to and above normal level by 64.6% of the female college students. However, female college students who are within the normal range of body composition value should notice that obesity will relate to abdominal or visceral fat on their body.

• 대한지역사회영양학회지
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• 제15권6호
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• pp.806-819
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• 2010

We investigated the foodservice sanitation status of the childcare centers in Chungnam Asan area to provide the information for sanitation guidelines and checklist in various operation types of childcare centers. Self-completed questionnaires were collected from the directors of 95 centers: national-public 9 (9.5%), corporation 10 (10.5%), private 52 (54.7%), and home care 24 (25.3%) types. The analyzed results are shown in foundation type; the investigated items are about critical hygienic problems and safety recognition level, presence of sanitation guideline, demand of dietian's employment and the role, hygienic management and education level, and the present and future of sanitary facility and equipment. From this study we found that home care center, which had low capacity, was comparatively poor at sanitation status, the use of hygienic standard and guideline, and safety recognition level. In our opinion, the use and application of same sanitation standard to any type and size of center is not appropriate and rational. The reestablishment of the sanitation guideline and checklist considering the conditions of various operation types would be necessary. Also periodic hygienic education by hygenic professionals, continuous parents' attention and cooperation of related government organizations are needed for improvement of foodservice sanitation status of childcare centers.

• 한국유기농업학회지
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• 제8권3호
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• pp.17-34
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• 2000

This paper is aim to report the core aspects of Codex guideline for organically grown food which is finalized by FAO/WHO Codex Alimentarius Commission on May 2000 in 28th session of the Codex committee on food labelling. The chapter of animal production had discussed for a long time before it was finalized in Ottawa/canada as well as use of GMO(Genetically modified organism), manure from factory farming, animal welfare, and fodder inputs consisting of at least 85% for ruminants and 80% for non-ruminants. As the guideline for Codex set out the several things which is very difficult for Asian country, Organic farmer in Korea should pay an attention to maintain/increase the fertility and biological activity by cultivation of legumes, green manures or deep-rooting plants in an appropriate multi-annual rotation programme, and incorporation in the soil of organic material from holding producing in accordance with the guidelines. Pest, diseases and weeds should be controlled by choice of appropriate varieties, appropriate rotation, mechanical cultivation, diversified ecosystems, flame weeding, animal weeding and steam sterilization. The use of plant growth hormone, GMO and manure from industrial management system are not allowed, and closed recycling system, rotation, resistant seeds again pest and disease should be practiced in organic farming. But these are not unfortunately practiced in the country. In the conclusion it was strongly suggested to enact the Basic Standard for Korean organic agriculture which contains the core principles of Codex guidelines, and to try the importation of the most advanced theory, skills and technology from leading country in organic farming.

• 농촌계획
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• 제25권2호
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• pp.35-45
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• 2019

This study revises current feasibility evaluation guideline for agricultural infrastructure improvement project considering recent changes in social and economic environment in rural area. We use an AHP(Analytic Hierarchy Process) approach to consider qualitative evaluation items in policy enforcement and balanced regional development as well as quantitative items in current economic analysis in the process of feasibility evaluation and decision making. The criteria system is composed of three level hierarchy. In the first level which consists of economic analysis, policy analysis, and regional development analysis, economic analysis was ranked top with relative weight of 0.45 and regional development analysis the lowest with 0.22. In the second level which consists of three evaluation items under policy analysis, consistency in policy enforcement, risk factors, and special evaluation factors, consistency in policy enforcement was ranked top. Finally, 13 detailed evaluation items in the third level were surveyed and ranked by using a comprehensive criticality vector. The result shows that the three most important evaluation items are 'degree of underdevelopment', 'spill-over effect of regional economy' and 'consistency with related planning and policy direction'.

• Journal of Pharmaceutical Investigation
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• 제35권1호
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• pp.57-63
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• 2005

Numerous drugs are chiral because they possess one or more chiral centers. Enantiomers may differ in their pharmacokinetic, pharmacological and toxicological properties. However, the significance of stereochemistry of drugs in their therapeutic uses has received relatively little attention until recently. The US FDA issued a guideline on stereoisomeric drugs in 1992, and the European agency describes tests for new drug substances which are optically active in an ICH(International Conference of Harmonization) guideline. According to the guidance, enantiomers may differ in their pharmacokinetic, pharmacological and toxicological properties. Therefore, in this paper, we examined the recently published Canadian guidance, stereochemical issues in chiral drug development, which will be references to make a guidance on stereochemical issues in chiral drug development in Korea.

• 한국축산식품학회지
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• 제29권6호
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• pp.673-679
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• 2009

To develop ready-to-eat (RTE) style Korean traditional Galbi-jjim, the optimal conditions for sous-vide cooking and cookchill preparation and the sensory properties of the cooked products were investigated. During heating, the meat core temperatures reached $85^{\circ}C$ within 30 min and 45 min when a water bath and combination oven were used, respectively. Chilling to $3^{\circ}C$ within 45 min was conducted to meet the standards for microbiological safety set by the UK Department of Health and Social Security (DHSS) Guideline. Galbi-jjim that was vacuum-cooked in a water bath was much more tender than that of Galbi-jjim prepared using the cook-chill method, but had no difference in any reheating methods. The average sensory scores of juiciness and the overall acceptance of Galbi-jjim were significantly higher when water bath cooking was used, and there were no differences in reheating methods. In conclusion, the serial methods of sous-vide processing and rapid chilling can be applied to produce RTE traditional Galbi-jjim, and this can be conducted while meeting the standards specified in safety guidelines.

• 농촌계획
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• 제22권2호
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• pp.57-65
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• 2016

Landscape elements of historical and cultural value and elements that have negative impact on landscape due to reckless development teem in rural area. Due to this, local government has established a visual landscape plan. The purpose of this study is to analyze the process and content of domestic rural landscape planning process and to suggest improvements for it. For that, this study measure guideline of Ministry of Agriculture, Food and Rural Affairs against guideline of Ministry of Land, Infrastructure and Transport. To analyze the landscape planning guideline of australia which is similar to domestic rural landscape planning process, and to compare both guidelines. The results of this study are as follow. The stage of landscape resource survey and assessment progressed systematically, but it was not practical because for the lack of survey and assessment method. Therefore, it should be suggested for the survey and assessment technique. The rural landscape plan, established in master planning stage, do not necessarily reflect local government's landscape management on the ground of abstract technic of landscape management. For this sake, to develop evaluation method for development of landscape element seems necessary.

• 한국환경농학회지
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• 제38권1호
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• pp.1-9
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• 2019

BACKGROUND: Accurate and simple analytical method determining Fluxametamid residue was necessary in various food matrices. Additionally, fulfilment of the international guideline of Codex (Codex Alimentarius Commission CAC/GL 40) was required for the analytical method. In this study, we developed Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) method to determine the Fluxametamid residue in foods. METHODS AND RESULTS: Fluxametamid was extracted with acetonitrile, partitioned and concentrated with dichloromethane. To remove the interferences, silica SPE cartridge was used before LC-MS/MS (Liquid Chromatography-Tandem Mass Spectrometry) analysis with $C_{18}$ column. Five agricultural commodities (mandarin, potato, soybean, hulled rice, and red pepper) were used as a group representative to verify the method. The liner matrix-matched calibration curves were confirmed with coefficient of determination ($r^2$) greater than 0.99 at calibration range of 0.001-0.25 mg/kg. The limits of detection and quantification were 0.001 and 0.005 mg/kg, respectively. Mean average accuracies were shown to be 82.24-115.27%. The precision was also shown to be less than 10% for all five samples. CONCLUSION: The method investigated in this study was suitable to the Codex guideline for the residue analysis. Thus, this method can be useful for determining the residue in various food matrices as routine analysis.